Kornimate/medical-research-clean huggingface dataset:
assess the efficacy and safety of personalized prophylaxis human-cl rhfviii in patients with severe haemophilia a

Conditions: Severe Haemophilia A

Summary: the rationale of this study is to further fine-tune and individualize prophylactic treatment of patients with severe haemophilia a with the goal of keeping the trough fviii level above 1% between doses. because trough fviii levels are likely to be important predictors of the efficacy of prophylaxis, the focus of this study is on pharmacokinetic (pk) data.


Eligibility criteria:
inclusion criteria: * severe haemophilia a (fviii:c \< 1%) * male patients \>= 18 years of age * previous treatment with a fviii concentrate for at least 150 eds * good documentation regarding dosing and bleeding frequency in the 6 months preceding study start * immunocompetence (cd4+ count \> 200/ul) exclusion criteria: * any coagulation disorder other than haemophilia a * present of past fviii inhibitor activity * severe liver or kidney disease
low-level laser therapy versus offloading exercises on foot ulcer healing in patients with type 2 diabetes

Conditions: Diabetic Foot Ulcer (DFU)

Summary: the goal of this clinical trial is to evaluate the effect of extravascular low-level laser therapy (lllt) versus offloading exercises on foot ulcers healing (dfus) in type 2 diabetic patients. could include sixty patients with type 2 diabetes associated with diabetic foot ulcer as a complication, their ages ranging from 45 - 55 years. patients will be selected from faculty of medicine (kasr al-aini) cairo university. they will be referred by the physician after a complete medical evaluation. . the main question it aims to answer is there any significant difference between extravascular low-level laser therapy and offloading exercise on diabetic foot ulcer healing in type 2 diabetic patients ? after clinical assessment patients will be randomly allocated into three groups equal in number: group (a) (experimental a): will receive extravascular low level laser therapy lllt (laser watch device) combined with their prescribed hypoglycaemic medications(oral and insulin) and usual wound care for 12 weeks (3 sessions/ week). group (b) (experimental b): will receive offloading exercise inform of burger allen exercise combined with their prescribed hypoglycaemic medications(oral and insulin) and usual wound care for 12 weeks (3 sessions/ week). group (c) control group will receive their prescribed hypoglycaemic medications(oral and insulin) and usual wound care only for 12 weeks (3 sessions/ week).


Eligibility criteria:
inclusion criteria: * body mass index of 25-34.9 kg/m2. * glycated hemoglobin (hba1c) \&gt;7 %. * abp index absolute normal (1-1.3) * patient with polyneuropathy. * patient suffer from diabetes more than 5 years. * patient has chronic unhealed diabetic ulcer from 4 weeks up to 6 weeks. exclusion criteria: * patients with history of hypo- hyperglycemic coma. * uncontrolled cardiovascular complications. * malignancy, anemia, hemorrhagic diseases. * cardiac peace maker. * deep venous thrombosis. * osteomyelitis. * patients with monckeberg sclerosis. * photosensitivity to laser.

Keywords: low level laser diabetic foot ulcer blood glucose level
functional neuroanatomy and regional metabolism before and after treatment with duloxetine

Conditions: Depression

Summary: the findings may guide future investigations on novel therapeutic targets in depressive subjects. based on the depicted link between personality traits and altered brain metabolism and function, the latter might be used as supporting objective measures and possible biomarkers for increased depression risk.

interoceptive awareness (ia) is the awareness of bodily signals and has been highlighted as important in many early theories of emotion. william james was one of the first to present a psychological theory linking viscero-afferent feedback to emotional experience. the processing of bodily and thus interoceptive stimuli may be a crucial component in yielding empathy, since affective states are often assumed to involve awareness of one´s own bodily state. the assumption of a close relationship between interceptive awareness and empathy is further supported when considering the regions recruited during both processes, like the insula and the anterior cingulate cortex. although especially the affective component may implicate interoception and interoceptive awareness, the impact of interoception on empathy has never been evaluated behaviorally or neurophysiologically. also associated with altered insula and anterior cingulate cortex (acc) function is alexithymia. alexithymia, a personality trait, is marked by cognitive and affective features including difficulties in identifying and describing feelings as well as in distinguishing feelings from bodily sensations of emotional arousal. recent studies found a negative correlation between prefrontal glutamate (glu) and mental perspective taking as well as extraversion. even though several functional imaging studies investigated the neuronal signatures of interoceptive awareness and the personality trait alexithymia, little is known about the functional relevance of neurotransmitter concentrations

Eligibility criteria:
inclusion criteria: * acute depressive episode exclusion criteria: * major medical illness * history of seizures, head trauma with loss of consciousness * abnormal clinical laboratory test result, and pregnancy * atypical forms of depression * suicidal ideation * any additional psychiatric disorder * history of substance abuse or dependence * electroconvulsive therapy in the previous 6 months healthy subjects without any psychiatric, neurologic, or medical illness

Keywords: empathy interoceptive awareness fmri mrs
telematic model integrated in the transversal care of the secondary prevention of patients with stroke

Conditions: Stroke; Risk Factor, Cardiovascular

Summary: in spain, stroke is the leading cause of death in women and disability in adults, which is why it is currently one of the most important public health problems. it is known that the main cause of stroke is the lack of control of cardiovascular risk factors (crf). strategies have been diversified for patients with severe neurological involvement, while those without or with mild involvement, susceptible to repeat a stroke, have a very heterogeneous approach. objective: design, implement and evaluate the effectiveness of the transversal telematic model of secondary prevention in patients who have suffered a stroke. methodology: randomized clinical trial with a control group, open and multicentre. a total of 70 patients (35 per group) will be included who meet all the inclusion criteria and none of exclusion, attended by an acute stroke in the hospital verge de la cinta de tortosa. variables: sociodemographic and clinical, frc, stage of change, therapeutic compliance and cv. outcome variables: impact of the stroke using the scale (sis-16); control of crf, new vascular events and mortality at 3, 6, 12, 18 and 24 months, integrable in the practice and computerized clinical history (hci). interventions: control and education for the patient's health to promote self-care and empowerment, and enhance pharmacological compliance. the telematic model has been developed through clinical practice guides of primary care and the most recent publications on the subject referenced. export of data directly from the hci. analysis of results with the spss 23.0 program, using regression and survival models.


Eligibility criteria:
inclusion criteria: * male and female patients ≥18 years old, diagnosed of established ischemic stroke and / or tia and attended by the htvc neurology service, on discharge from home and with habitual residence in the ebro lands to be able to follow up . * informed consent of the signed study. exclusion criteria: * patients suffering from other neurological injuries that interfere with the follow-up (established strokes, with or without mca deviation, glioblastomas, etc.), life expectancy \<6 months, modified rankin scale score (mrs) ≥3 and present language barrier and / or aphasia.

Keywords: nurse's role quality of life adherence risk factors stroke secondary prevention
a study on the usability of the needle-free intraject® system in adult patients during acute migraine attack

Conditions: Migraine Headache

Summary: intraject is a needle-free, single use, disposable, subcutaneous delivery system pre-filled with 6mg sumatriptan to be used by patients to treat acute migraine treatment. study participation will last one month and include 2 doctor visits and 2-4 phone calls.

this study will evaluate how patients will interact with the needle-free intraject system during actual self-administration to the abdomen or thigh for treatment of migraine headache while outside the clinic.

Eligibility criteria:
inclusion criteria: * have a diagnosis of migraine with an average of ≥2 to ≤6 attacks/month * female subjects of child-bearing potential must agree to use acceptable birth control * have abdominal or thigh injection sites that have sufficient subcutaneous tissue for needle-free injection * fluent in the spoken and written english language * provide written informed consent to participate in the study and be willing to comply with the study procedures * access to a telephone for call center interactions exclusion criteria: * a history, symptoms, or signs of ischemic cardiac, cerebrovascular, or peripheral vascular syndromes including ischemic or vasospastic coronary artery disease * other significant underlying cardiovascular diseases including uncontrolled hypertension * hemiplegic or basilar migraine * a history or diagnosis of severe hepatic or renal impairment * a history of epilepsy or seizure or other serious neurologic condition * a history of allergy, anaphylaxis, or hypersensitivity to sumatriptan or any of its components or similar drugs * a history of scleroderma (systemic sclerosis) or any skin condition that may adversely affect the injection or absorption of subcutaneously administered medications * tattoos in the thigh or abdominal area that are large enough to restrict injection site selection and/or evaluation * birthmark or other significant skin discoloration in the thigh or abdominal area large enough to restrict injection site selection and/or evaluation * pregnancy or breast-feeding * have participated in a clinical trial or receipt of an experimental therapy within 30 days prior to dosing

Keywords: migraine sumatripatan
long-term efficacy of carglumic acid in organic acidemia.

Conditions: Propionic Acidemia (PA) , Methylmalonic Acidemia (MMA)

Summary: evaluate the long term effectiveness \& safety of the use of carglumic acid (carbaglu®) in patients with propionic acidemia (pa) or methylmalonic acidemia (mma).

study procedures: a. study period: 36 months; treatment period: 12 months. b. patients will receive carglumic acid (carbaglu®) 50 mg/kg/day in addition to standard therapy (protein restricted diet, l-carnitine, metronidazole and vitamin b12). c. patients need to regularly come back for follow up examination on day 0, month 3, month 6, and month 12. d. patients should report any adverse event that occur during treatment period. e. patients' number of emergency visits due to hyperammonemia, ammonia level, acylcarnitine, urinary organic acid analysis, plasma amino acid analysis and methylmalonic acid will be recorded during treatment period.

Eligibility criteria:
inclusion criteria: 1. pa or mma confirmed using the following criteria: * pa confirmed by the measurement of acylcarnitine profile, urine organic acid, measurement of propionyl co-a carboxylase in leukocytes or cultured fibroblasts or by dna molecular testing of pcca (propionyl coa carboxylase, alpha polypeptide) or pccb (propionyl coa carboxylase, beta polypeptide) gene * mma confirmed by the measurement of acylcarnitine profile, urine organic acid, measurement of methymalonyl co-a mutase in culture fibroblasts or dna molecular testing of mutgene. 2. male or female children of 18 years old or less. 3. had experienced hyperammonemia(nh3 ≧100 um) before. 4. not participating in any other clinical trial in the previous 30 days exclusion criteria: 1. patients with other organic acidemia or any other cause of hyperammonemia 2. patient receiving other investigational therapy for pa or mma 3. patient with pa or mma and other inherited genetic conditions or congenital anomalies 4. past history of hypersensitivity or drug allergy to carbaglu®

Keywords: carglumic acid (carbaglu®)
hypotension prediction index study (hpi study)

Conditions: Hypotension

Summary: a prospective, single-arm, open-label, multicenter post-approval study to determine whether the use of the acumen hpi software to guide intraoperative hemodynamic management in non-cardiac surgery reduces the duration of intraoperative hypotension below a threshold of mean arterial pressure (map)


Eligibility criteria:
inclusion criteria: 1. written informed consent; 2. age ≥ 18 years; 3. asa physical status 3 or 4; 4. moderate- or high-risk non-cardiac surgery (for example, orthopedic, spine, urology, and general surgery); 5. planned pressure monitoring with an arterial line; 6. general anesthesia; 7. surgery duration expected to last ≥ 3 hours from induction; 8. planned overnight hospitalization. exclusion criteria: 1. participating in another (interventional) study; 2. contraindication to the invasive blood pressure monitoring; 3. patient who is confirmed to be pregnant and/or nursing mothers; 4. emergency surgery; 5. known clinically important intra-cardiac shunts; 6. patient in whom an intraoperative map target will be \< 65 mmhg; 7. known aortic stenosis with valve area ≤ 1.5 cm2; 8. known moderate to severe aortic regurgitation; 9. known moderate to severe mitral regurgitation; 10. known moderate to severe mitral stenosis; 11. patient or surgical procedure type known as an svv limitation (5) (e.g. tidal volume \<8ml/kg of theoretical ideal weight, spontaneous ventilation, persistent cardiac arrhythmia, known atrial fibrillation, open chest surgery, heart rate/respiratory rate (hr/rr) ratio \<3.6); 12. current persistent atrial fibrillation; 13. known acute congestive heart failure; 14. craniotomy; 15. surgery duration expected to last \< 3 hours; 16. burn surgeries; 17. patients with an intra-aortic balloon pump (iabp) or ventricular assist device(s); 18. patient transfer from icu requiring multiple vasoactive agents and known diagnosis of ongoing active sepsis.
application breathing exercises with load inspiratory postoperative abdominal surgery

Conditions: Pulmonary Atelectasis; Respiratory Tract Diseases; Pathological Conditions, Signs and Symptoms

Summary: the aim of this study is to evaluate the effects of the use of breathing exercises with inspiratory loading on respiratory muscle strength and endurance, lung volumes and capacities and thoracoabdominal mobility in patients after bariatric surgery. it is believed that the use of inspiratory load may mitigate the negative effects of surgical trauma on respiratory muscle dysfunction, preserving respiratory muscle strength, lung volumes and diaphragm mobility, thus reducing the risk of pulmonary complications in the postoperative period.

this is a prospective, randomized and blinded study, where volunteers will be selected anthropometric measurements, assessment of lung volumes and capacities, through spirometry, thoracoabdominal mobility through the circumference, assessment of inspiratory muscle strength and endurance. after these evaluations will be done by lottery randomization, where the volunteers will be divided into five groups. they are: control, incentive spirometry to flow, the volume incentive spirometry, threshold ™, power breathe ®, according to their resources to be performed during the postoperative period. each appeal will be held in 6 sets of 15 repetitions, totaling seven sessions, two in the immediate postoperative period, and five on the first postoperative day. at the end of the intervention volunteers will be reassessed.

Eligibility criteria:
inclusion criteria: * bmi between 40 and 55 kg/m² * aged between 25 and 55 years * submitted to roux-en-y type gastric by-pass by laparotomy * normal preoperative pulmonary function test exclusion criteria: * hemodynamic instability * hospital stay longer than three days * presence of postoperative complications * smoking

Keywords: morbid obesity bariatric surgery respiratory muscle endurance respiratory muscle strength spirometry physiotherapy
personalized digital remote monitoring for elderly patients

Conditions: Elderly Patients; Polypathology; Multiple Chronic Conditions

Summary: objective this clinical investigation aims to evaluate whether the epoca remote monitoring system (rms) enhances care for elderly patients with multiple chronic conditions and reduces unplanned hospitalizations. key research questions this study will assess: * unplanned hospitalizations: does epoca rms reduce the total number of unplanned hospital days over 12 months? * quality of life \& costs: what is the impact of epoca rms on patients' quality of life and overall healthcare costs? * survival rates: does epoca rms improve survival rates compared to standard care? participant criteria participants must: * be 75 years or older with at least three chronic conditions. * have experienced a hospitalization or fall in the past year. * be randomly assigned to either the epoca rms group or a control group receiving standard care. * be monitored for 12 months, with data collected at multiple time points. study design * type: multicenter, randomized controlled trial (rct). * sites: conducted across 8 hospitals in france. * duration: 12-month follow-up. * sample size: 700 participants (350 per group). * intervention group: remote monitoring through the epoca rms, integrating connected devices and medical coordination. * control group: standard care follow-up. expected outcomes * reduced unplanned hospital stays and emergency visits. * improved quality of life and patient satisfaction. * comprehensive cost-effectiveness analysis and economic impact assessment.


Eligibility criteria:
inclusion criteria: * age ≥ 75 years, * three or more chronic pathologies (e.g., diabetes, heart disease, depression, cancer, respiratory failure, renal failure, dementia), * hospitalization or fall at least once in the previous year (y-1), * recently discharged from the emergency department (within 24 hours), * patients, with or without caregivers, who accepted to participate and provided informed consent. exclusion criteria: * patients discharged to or having been institutionalized in nursing homes (ehpad), * patients enrolled in another clinical trial * suicidal or hetero-aggressive risk in a patient alone at home, * homeless patients, * patients protected by the following french legal measure: "sauvegarde de justice"

Keywords: elderly hospitalization decompensation multiple chronic conditions remote monitoring
development of an it tool able to identify ocular conditions

Conditions: Eye Diseases

Summary: the aim of the study is to use machine learning to develop an it tool able to differentiate between eye conditions analysing corneal biomechanical data.

data will be collected using two different commercially available devices that are able to measure corneal biomechanics. corneal biomechanics will be measured in participants with different conditions: glaucoma, ocular hypertension, corneal conditions, and healthy controls as it is well established that the above-mentioned conditions cause changes in corneal biomechanical properties. corneal biomechanics are the mechanical properties of the cornea, as rigidity, elasticity and it is possible to measure them using two devices: ocular response analyzer (ora) or corneal visualization scheimpflug technology (corvis st). both devices use a puff of air to temporally flatten the cornea and derive the properties of the tissue. participants with ocular conditions will be recruited at birmingham and midlands eye centre (bmec) at the glaucoma and anterior eye clinics among patients attending for their routine clinical appointment. healthy controls will be recruited at aston university. this study requires only one visit and there is no need of follow up. a portion of the data collected will be used to train machine learning algorithms to differentiate between conditions, the remaining data will be used to test the accuracy of newly created algorithms. the algorithm will be developed using orange data mining.

Eligibility criteria:
inclusion criteria: * age above 18 years old. * participants who are able to give informed consent. * study groups: patients with diagnosis of glaucoma or corneal disease or ocular hypertension. patients that are having a treatment (medications or surgery) for glaucoma or ocular hypertension or corneal conditions. * control group: people with no diagnosis or treatment of previous pathologies. exclusion criteria: * age below 18. * participants who are not able to give informed consent. * patients with eye conditions not within the inclusion criteria. * patients with respiratory distress or significant head tremor. * patients who are in pain or unable to remain seated for duration of measurements. * participants that during the visit are wearing contact lenses. the wear of contact lenses can alter the measure of corneal biomechanics.

Keywords: machine learning glaucoma keratoconus ocular hypertension corneal biomechanics
post injury performance deficits in rink hockey

Conditions: Injuries; Sports Physical Therapy; Non Contact Injury; Performance

Summary: rink hockey is a sport played on a 40\*20 metres rink characterized by combined periods of high intensity and short breaks, there´s a lack of epidemiological studies in this field. in line with the well-established model of sports injury prevention research proffered by van mechelen, the first stage in this process is establishing the extent of the problem i.e. injury incidence, severity and burden.

this study will assess performance metrics from rink hockey athletes and injury epidemiology. 4 tests (to be specified yet) will evaluate players fitness during preseason and when a player suffers a non-contact injury during the season, the player will be retested to assess variability and performance deficits. injury characteristics and exposure time will be recorded too

Eligibility criteria:
inclusion criteria: * compete in senior league * be uninjured during preseason exclusion criteria: * not signing the participation consent * no participation in the performance assessment during preseason